Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Company (NYSE: LLY) is set to present new data from Phase 3 studies at the virtual EULAR Congress (June 2-5, 2021), demonstrating Taltz's long-term efficacy and safety in axial spondyloarthritis (axSpA). In the COAST-Y study, continuous Taltz treatment showed that 56.7% of patients achieved ASAS40 after two years. Additionally, 89.6% of patients experienced no bone damage progression. Taltz has treated over 175,000 patients globally, supporting its use for multiple inflammatory conditions.

Eli Lilly's Phase 2 SERENITY study revealed that mirikizumab significantly alleviates fatigue in patients suffering from moderately to severely active Crohn's disease. At 12 weeks, patients receiving mirikizumab showed marked improvements in FACIT-Fatigue scores compared to placebo. This positive effect was sustained over one year. The study underscores the significance of fatigue as a symptom that correlates with disease activity and quality of life. This data is being showcased at Digestive Disease Week (DDW) 2021, reaffirming the need for innovative treatments for inflammatory bowel diseases.

Eli Lilly's tirzepatide achieved significant A1C and body weight reductions in adults with type 2 diabetes at increased cardiovascular risk in the SURPASS-4 clinical trial. The highest dose showed an A1C reduction of 2.58% and a weight loss of 11.7 kg compared to insulin glargine, which had an A1C reduction of 1.44% and weight gain. The study met all primary and secondary endpoints, demonstrating the potential of tirzepatide as a treatment option. A regulatory submission is planned by the end of 2021.

New data from Eli Lilly's oncology portfolio will be showcased at the 2021 ASCO Annual Meeting from June 4-8, 2021. Key highlights include a subgroup analysis of Verzenio® (abemaciclib) from the Phase 3 monarchE trial focused on hormone receptor-positive breast cancer and a first look at clinical data for Lilly's oral selective estrogen receptor degrader. Additionally, updates on Retevmo® (selpercatinib) for lung and thyroid cancer will be presented, alongside findings related to CYRAMZA® and ERBITUX® in gastrointestinal cancers, emphasizing treatment outcomes and patient demographics.

Innovent Biologics and Eli Lilly announced that the U.S. FDA has accepted for review a Biologics License Application (BLA) for sintilimab injection combined with pemetrexed and platinum chemotherapy for first-line treatment of nonsquamous non-small cell lung cancer (NSCLC). This landmark application marks the first submission of sintilimab outside of China, following its regulatory approval in China earlier in 2021.

The FDA plans to decide by March 2022, with no review issues identified at this stage.

Eli Lilly will participate in the UBS Global Healthcare Virtual Conference on May 26, 2021, at 10:00 a.m. ET. Anat Ashkenazi, CFO, will engage in a virtual fireside chat during the event. A live audio webcast will be hosted on Lilly’s Investor website, with a replay available for 90 days. Founded over a century ago, Eli Lilly is dedicated to discovering and delivering innovative medicines globally. To learn more about the company, visit www.lilly.com.

Eli Lilly and Company (NYSE: LLY) has entered a global research collaboration with MiNA Therapeutics to explore novel drug candidates using MiNA's small activating RNA (saRNA) technology. MiNA will investigate up to five targets identified by Lilly, which will handle preclinical and clinical development, retaining exclusive commercialization rights. MiNA will receive a $25 million upfront payment and is eligible for additional milestones totaling $245 million per target. The collaboration is expected to enhance Lilly's RNA therapeutics portfolio without impacting its 2021 non-GAAP earnings per share guidance.

Eli Lilly and Company (NYSE: LLY) announced strategic partnerships with DexCom, Glooko, myDiabby Healthcare, and Roche to enhance diabetes management through connected technology. These collaborations aim to integrate their diabetes management platforms with Lilly's Tempo Pen and Tempo Smart Button, expected to improve real-time data tracking for insulin users. Lilly seeks CE marking for the Tempo Smart Button later in 2021 and plans to launch these products internationally. The initiatives target the growing diabetes community, addressing management challenges and improving treatment outcomes.

Eli Lilly and Company (NYSE: LLY) will participate in the Bank of America Securities 2021 Health Care Conference on May 11, 2021. Senior VP Michael Mason, who leads Lilly Diabetes, will engage in a virtual fireside chat at 9:30 a.m. Eastern Time. A live audio webcast will be accessible on Lilly's Investor website, with a replay available for 90 days.

Lilly continues its mission to create high-quality medicines, supporting global health through discovery and community engagement. For more information, visit www.lilly.com.